Chris Learn, Head of Cell and Gene Center of Excellent at Parexel, discusses his participation at the recent Clinical Research Virtual Summit hosted by the Society for Immunotherapy of Cancer, and the implications for clinical research.
In this third episode of the Decentrally Speaking series, we explore the topic of Integrating the Patient Voice into Decentralized Trials. Join our guests from AstraZeneca, who partnered with Parexel to deploy a fully virtual clinical trial. We’ll learn how the team incorporated the patient voice within trial planning and execution, some of the innovative approaches used in the trial, and lessons learned to take forward into future trial design. Rosamund Round, Vice President, Patient Innovation...
By designing quality into trials, we focus on the most critical data and create a framework for efficiently identifying and addressing any risks to patients, the integrity of data, or regulatory compliance. While part of regulatory guidance, consistent interpretation of RBQM approaches by regulatory inspectors is an area of concern. In such a highly regulated industry that is notably slow to adopt change, biopharmaceutical companies and CROs are still debating how to go with evidence-backed docu...
In this second episode in the Decentrally Speaking series, we will be discussing how pharmaceutical depots are evolving their services and operations to support both sites and patients as a critical part of decentralized trials (DCTs). Expanding geographies, ancillary procurement, and storage of investigational drugs and supplies to be shipped either direct to patient or direct to site create a complex supply chain that must be carefully managed and controlled. Join our Parexel clinical trial su...
As risk-based quality management (RBQM) practices become a requirement of global regulators, industry adoption will require end-to-end organizational change. In this second episode of our RBQM series, Amy Kissam-Sands, Senior Vice President of Clinical Operations, Dr. Kristin Murphy, Senior Director and Global of the Change in Adoption Center of Excellence, and Amy Adams, Senior Director of Clinical Operations, discuss the key questions and practices that form a robust change management strategy...
Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials (DCTs). Join us as we also explore opportunities to operationalize DCTs across our industry. In this first series episode, we will be discussing operational experiences and best practices in optimizing inclusivity for patients from Under-Represented Communities (UCs). We’ll share ideas for trial recruiting, protocol review, pati...
Researchers have identified more than seven thousand rare diseases, but effective treatments are available for fewer than ten percent. Drug development for rare diseases is complex given the challenges of the limited, geographically dispersed patient populations, many of which are children. In this Parexel podcast episode we explore those challenges with rare disease experts: Dr. Lucas Kempf, Vice President, Regulatory Affairs at Parexel, who has former rare disease regulatory experience at the ...
Risk-based quality management (RBQM) is fast becoming a critical success factor for clinical development programs. Global regulatory agencies are putting more focus on RBQM components to ensure patient safety, data quality and the validity of study results. However, companies don’t always approach risk management in a holistic, collaborative approach increasing their chances of missing risk signals. In this Parexel podcast episode, the first of our RBQM five-part series, RBQM experts Amy Adams, ...
The biotech industry posted record financing, deals, and M&A numbers in 2020 and 2021, spurred in part by the swift and successful development of COVID-19 vaccines. Despite this favorable funding environment, the industry faces ongoing challenges. The cost of developing new therapies continues to climb and fewer than 8% of product candidates make it from Phase I to market. In this episode, biotech experts – Jim Anthony, Executive Vice President and Global Head of Parexel Biotech, and Mike Da...
In the United States, the FDA and CDC recently granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine for 5–11-year-olds, making it the first COVID-19 vaccine available for younger children and arriving nearly one year after Pfizer’s COVID-19 vaccine received EUA for adults. If the adult vaccine was authorized for this long, why did it take so long to make one available for younger children? In today’s episode, Nathalie Sohier, Global Head of Infectious Disease and Vaccines, and...
Viral infections continue to emerge and represent a serious threat to global public health, from SARS to H1N1 influenza to MERS. Yet none has caused the level of global devastation levied by the coronavirus. In fact, the long-term complications of COVID-19 on our healthcare system are just beginning to come into focus. Managing these complications will increase the demand for healthcare resources in the years to come and will elevate the need for novel therapies to manage them. This episode feat...
Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet the vast majority of medications are only evaluated in adults, and pediatric participation in clinical trials remains exceedingly low worldwide. In this podcast, experts discuss critical insights gleaned from a survey of 500 parents and children about their perceptions and experiences of clinical research...
Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief Commercial and Strategy Officer, talks with Paul Bridges, Worldwide Head of Regulatory and Access, and Sheela Hegde, a Partner with Parexel’s Health Advances subsidiary, about the regulatory, investing and clinical development changes that are most likely here to stay – The New Pragmatism . After listenin...
In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster, MD, Head of Parexel’s Oncology Center of Excellence; Matthew Cooney, MD, co-lead of Parexel’s Cell and Gene Therapy initiative; and Keith Donovan, an expert in Early Phase Development with a focus on oncology, join Alberto Grignolo, Corporate Vice President, Regulatory and Access, to discuss the progre...
Now more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19 pandemic we've seen many changes that have been made to clinical trials to maintain continuity. In this podcast, we explore how clinical trials have changed and adapted, and how those changes may impact clinical trials in the future for patients. Ken Getz, professor at Tufts University School of Medicine a...
The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs). Today, wearables are enabling at-home care and providing long-term monitoring of COVID-19 patients. How can wearables change the game in this most critical time for our industry? What considerations need to be kept in mind when involving wearables in a clinical trial? Julia Lakeland, solutions architec...
In this episode, we discuss how Functional Service Provider or FSP partnerships have been gaining traction and increasing in relevance in today’s environment because of their potential to offer flexibility, access to expertise, and reduce costs in outsourcing without compromising quality. Parexel’s Head of Global FSP Chris Baker discusses with FSP leaders Joanne Sullivan, Alisdair Falconer and Beth Shaleesh several “tips and tricks” for making the most of FSP relationships, how Parexel has built...
The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leader...
In this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending Davos: A Career Journey from the Emergency Room to the Boardroom. The two healthcare leaders discuss topics including Meghan’s career pivots from nursing to the healthcare industry to private equity, why you should take your CFO to lunch, and their unexpected friendship.
Within the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more companies leveraging this approach? In this episode, Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss this conundrum, and what biotechs should be thinking about right from the start, to open up the opportunity for this approach to help bring innovation and new ther...
In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days. Parexel’s experts Mo Heidaran, Alexander Gee and host Alberto Grignolo, all part of our newly-integrated Regulatory & Access consulting unit, also weigh in on the current regulatory and reimbursement landscape for CAR-T and what we might look forward to in the future for this and other cell and gene therapies....
In this episode Alberto Grignolo, Corporate Vice President, Parexel, Sy Pretorius, Executive Vice President and Chief Medical and Scientific Officer, Parexel, and Roz Round, Director of Parexel's Patient Innovation Center, team up to discuss how the clinical research industry can bridge the gap between the scientific needs of research and development and the needs of patients. Stemming from feedback based on a survey looking at perceptions of clinical trials, the episode explores current barrier...
Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe , an expert in rare disease drug development. Amy, Mo and Zizi discuss how the industry can work to deliver more innovative treatments for rare disease patients and the reality of working with the Food and Drug Administration (FDA). In the first segment, the experts share their insights working with the rare diseas...
In our inaugural podcast, Siri Chilazi, a gender equality expert and Harvard Kennedy School Research Fellow, speaks with female leaders from PAREXEL - Dr. Kemi Olugemo, Dr. Ubavka DeNoble, Aida Sabo, and Peyton Howell - in celebration of International Women’s Day. They discuss what it means to be a female leader in a STEM field and what challenges they have faced throughout their journeys, with the hope that their stories and lessons learned will inspire other young women currently rising throug...
